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New information about CEPs and inspections published by EDQM….see about Telangana, India

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Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL:

The European Directorate for the Quality of Medicines & Healthcare (EDQM) has published new information about the CEP procedure and its related inspections. Please read more about he latest updates from EDQM.

http://www.gmp-compliance.org/enews_4746_New-information-about-CEPs-and-inspections-published-by-EDQM_9196,S-WKS_n.html

The European Directorate for the Quality of Medicines & Healthcare (EDQM) has published new information about the CEP procedure and its related inspections.

1) Costs of inspections

The EDQM has published a new document which describes the inspection costs. The EDQM document PA/PH/CEP (12) 28 1R refers to a table of fees and inspection costs. The costs for the inspection as well as for the travel will be invoiced prior to the inspection. For a three day inspection, for example, the fee is 5000,- Euro. If the facility is located in Asia a flat rate of 6000,- Euro will be charged to cover the travel costs, food and accommodation for the inspector. The travel costs are less…

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Filed under: Regulatory, Uncategorized Tagged: CEP, EDQM, fda, TELANGANA

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